Forms, Resources, Labeling and Schedule drugs rules

  1. OTC Labels require:
    • 1. name of product, address of manufacturer, packer, or distributor
    • 2. Net contents of package
    • 3. name of all active ingredients and qty
    • 4. name of any habit forming drugs
    • 5. adequate directions for use
  2. Prescritpion Labels require:
    • 1. name, address and phone # of dispensing pharmacy
    • 2. Patient and doctors name
    • 3. prescription number and the date the prescrition was filled
    • 4. name of drug, strength, qty and directions for use
    • 5. name or initials of dispensing pharmacist and/or technician
    • 6. Patients address
    • 7. Expiration date, refill information and any precautions
    • 8 "Federal law prohibits........
    • 9. Package insert on selected drugs
  3. Package inserts require:
    • 1. description of drug
    • 2. Clinical Pharmacology
    • 3. Indications and usage
    • 4. Contraindications, precautions, warnings, and adverse reactions
    • 5. Drug abuse, dependence and overdosage info
    • 6. Dosage, administration and how the drug is supplied
    • 7. Date of the most recent labeling revision
  4. Drug classes that require package inserts:(6)
    • 1. Oral contraceptives
    • 2. Estrogen-containing and progestational drugs
    • 3. Intrauterine contraceptive devices
    • 4. Diethylstilbestrol products
    • 5. Accutane
    • 6. Metered-Dose inhalers
  5. NDC code break down:
    • 1. first 5 are the manufacturer
    • 2. next 4 identify a specific drug
    • 3. last 2 identify the package size
  6. Schedule I rules
    • These drugs have NO accepted medicinal use in the US
    • These drugs have a high abuse potential
  7. Schedule II rules
    • These drugs may not be refilled
    • Ordering and returning of these drugs requires a DEA 222 form
    • These drugs have a high abuse potential, may lead to severe physical or psychological dependence
  8. Schedule III rules
    • May be refilled 5 times in a 6 month period
    • Have less potential for abuse or dependence
  9. Schedule IV rules
    • May be refilled 5 times in a 6 month period
    • Less potential for abuse or dependence
  10. Schedule V
    Less potential for abuse or dependence
  11. What must Schedule II-V have?
    An auxiliary label that states "Caution: Federal law probitits the transfer of this drug to any person other than the patient for whom it was prescribed"
  12. What form is used for the purchasing and returning of outdated CII drugs?
    DEA 22 form
  13. What form is used to report lost or stolen controlled substances?
    DEA 106 form
  14. What form is used to document the destruction of controlled substances?
    DEA 41
  15. What form is needed for a pharmacy to dispense controlled substances?
    DEA 224 form
  16. What form is needed to operate a controlled substance treatment program or compound controlled substances?
    DEA 363 form
  17. What form is needed to maufacture or distribute controlled substances?
    DEA 225 form
  18. Six steps to verify a DEA number
    • 1. first letter should be an A or B
    • 2. second letter should be the first letter of the physicians last name
    • 3. Add the 1st, 3rd, and 5th number
    • 4. Add the 2nd, 4th, and 6th number and multiply by 2
    • 5. Add the two sums together
    • 6. The last digit in the number should match the last number in the DEA
  19. What book compares therapeutic equivalency of drugs using an alphabetical rating system?
    Approved Drug Products with Therapeutice Equivalnce Evaluations (Orange Book)
  20. What book contains monographs and chemical characteristics of drugs?
    USP/NF US Pharmacopoeia/National Formulary
  21. What book is a 3 volume set:
    Volume I: Drug information written for a health care provider
    Volume II: Drug information written for a patient
    Volume III: Therapeutic equivalency information and pharmacy law
    USPDI US Pharmacopoeia Despensing Information
  22. What book contains a comprehensive listing of drugs and comparative drugs?
    Drug Facts and Comparisions
  23. What book gives a listing of drugs by pricing, strengths, sizes, maufacturers, brands and generics?
    Drug Topics Red Book
  24. What book lists injectable drug information such as compatability, storage and dosages?
    Handbook on Injectable Drugs
  25. What book contains packet insert drug information intended for physicians and is published annually?
    Physician's Desk Reference
  26. What book lists generic drugs in alphabetical order?
    Mosbys Complete Drug Reference
  27. What book has the drugs listed alphabetically and provides brand, generic and the chemical names of the drugs?
    American Drug Index
  28. What book is used to determine the compatibility of medications that will be used in an IV bag?
    The Handbook of Injectable Drugs
  29. What sheet provides information on hazardous materials that may be in the pharmacy and also provides information on diposal, storage, safe use and clean-up of these medications?
    Material Safety Data Sheets
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Forms, Resources, Labeling and Schedule drugs rules